Lead CRA

Job Title: Lead CRA

Job Number: 31999

Location: Remote, 

Job Description

This person will play a crucial role in being responsible for tasks that relate to the operations and management of clinical trials.  The Lead Clinical Research Associate may be located in-house in the HQ, a client’s office, or be regionally based.

Responsibilities

•  Monitoring:
• Acting as primary liaison between the study site staff and Sponsor Company
• Overseeing the study site staff to assess protocol compliance and appropriate data collection including proper handling, storage and shipment of biological samples
• Training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion
• Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues
• Reviewing investigational product accountability, including discrepancy resolution
• Processing or overseeing transmission of study data to sponsor according to protocol-specified timelines
• Reviewing data queries and listings, and working with the study site staff to resolve data discrepancies
• Visit report writing and site correspondence
• Monitoring clinical studies of investigational and approved products.  This may include qualification, initiation, interim monitoring, and close out site visits
• Monitoring studies by reviewing and reporting to the Sponsor on the following: site enrollment and subject status, findings at monitoring visits, protocol deviations/exceptions, serious adverse events and laboratory abnormalit
• Communications/Management:
• Interacting with project manager (sponsor or other) through formal and informal communications, including providing updates, identifying issues, sharing of information and instructions
• Supervision and guidance of CRAs, CTAs, and external CROs.  Conduct co-monitoring, training and audit visits.  Creation of visit report templates.  Review of completed visit reports
• Visit report writing and site correspondence
• Managing the resource requirements of the project
• Interdepartmental liaison working with regulatory, data management, biostatistics and clinical groups to develop and maintain clinical plan
• Document/Supply Tracking:
• Managing the preparation, collection and maintenance of trial regulatory documents
• Maintaining study files to ensure all appropriate documentation is present
• Managing, preparing, sending, tracking, and returning investigational supplies at individual sites
• Managing investigational product ordering, packaging, labeling and ongoing inventory
• Document/Presentation Preparation:
• Managing the reporting of serious adverse events
• Developing study-related documents such as protocols, case report forms, informed consent forms, study binders, standard operating procedures, study guidelines, study management/tracking tools, and monitoring plans
• Preparing contracts with investigators/hospitals, and negotiating budgets and payment schedules
• Planning, preparing for, and giving presentations at investigator meeting

Required Skills

• RN or Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training and previous CRA experience.